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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090745
Company: SUN PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/11/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090745Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2023 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/02/2023 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/02/2023 SUPPL-19 Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.
05/02/2023 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/02/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
05/02/2023 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/02/2023 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
05/02/2023 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/02/2023 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
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